Mallinckrodt announced the launch of its Morphine sulfate oral solution for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. This is the first FDA-approved generic morphine oral solution and it is available in 100mg/5mL dosage strength.
Mallinckrodt began marketing the 20mg/1mL in 2005 but this form and concentration of morphine had never been approved by the FDA. In April 2009, the FDA announced that manufacturers could keep morphine sulfate oral solution on the market, but only until the form and dose was approved or an equivalent therapy was available. Upon approval of a new drug application (NDA) by another manufacturer in January 2010, Mallinckrodt removed its product from the market and began the FDA approval process. In July 2011, the FDA granted approval of this product. The product is being launched with new packaging, including a plastic syringe dispenser with stopper that helps prevent spills.
Morphine sulfate oral solution is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
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